评估 NIH CTSA 计划对机构赞助临床试验的影响。
Assessing the impact of the NIH CTSA program on institutionally sponsored clinical trials.
机构信息
Penn State College of Medicine, Public Health Sciences, Hershey, PA, USA.
出版信息
Clin Transl Sci. 2013 Jun;6(3):196-200. doi: 10.1111/cts.12029. Epub 2013 Apr 18.
OBJECTIVE
To assess the impact of the NIH CTSA program on patient enrollment in clinical trials sponsored/collaborated by CTSA consortium institutions.
MATERIAL AND METHODS
Using publicly available clinical trial data at ClinicalTrials.gov, we identify positive trend changes in the number of patients enrolled in clinical trials performed at CTSA consortium institutions over the years before and after their respective CTSA award dates. CTSA consortium institutions were matched with similar non-CTSA institutions.
RESULTS
As compared to matched non-CTSA institutions CTSA consortium sites noted an increase in patient enrollment after the CTSA awards. In particular, we detected a change-point, where a new enrollment trend emerged, 338 days after the CTSA award. No such trend was noted over the same period in the non-CTSA institutions.
CONCLUSION
Our analysis provides evidence that the NIH CTSA funding program made a positive impact on patient enrollment.
目的
评估 NIH CTSA 计划对 CTSA 联盟机构赞助/合作的临床试验的患者入组的影响。
材料和方法
我们使用 ClinicalTrials.gov 上公开的临床试验数据，确定了 CTSA 联盟机构进行的临床试验中患者入组数量在各自 CTSA 授予日期前后多年的积极趋势变化。将 CTSA 联盟机构与类似的非 CTSA 机构进行匹配。
结果
与匹配的非 CTSA 机构相比，CTSA 联盟机构在获得 CTSA 奖后注意到患者入组增加。特别是，我们发现了一个变化点，即在 CTSA 奖后 338 天出现了新的入组趋势。在同期，非 CTSA 机构没有注意到这种趋势。
结论
我们的分析提供了证据表明，NIH CTSA 资助计划对患者入组产生了积极影响。
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